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NCT00775710 Clinical Trial

Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure

Hypercapnic Respiratory Failure Clinical Trial

Official title:
A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00775710
Other study ID # NIV-JS1
Secondary ID
Status Completed
Phase Phase 4
First received October 17, 2008
Last updated June 21, 2011
Start date March 2006
Est. completion date August 2010

Study information
Verified date October 2008
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Acute hypercapnic respiratory failure.

- Use of NIV to treat respiratory failure.

- Persistence of hypercapnia after discontinuation of NIV

Exclusion Criteria:

- Home NIV

- Facial or cranial trauma or surgery,

- Recent gastric or esophageal surgery,

- Active upper gastrointestinal bleeding,

- Excessive amount of respiratory secretions,

- Tracheostomy

- Lack of cooperation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Nocturnal non-invasive ventilation
Prolongation of non-invasive ventilation during 3 nights.

Locations
Country Name City State
Spain Hospital Clinic Barcelona
Spain Hospital de Sant Pau Barcelona
Spain Hospital del Mar Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation At the end of enrollment time No
Secondary Incidence of long term dependency on non-invasive ventilation At the end of enrollment time No
Secondary Hospital and 6-month survival At the end of enrollment time No
See also
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Not yet recruiting NCT06367686 - Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
Completed NCT03406572 - Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure N/A
Active, not recruiting NCT03364946 - High Flow Therapy in ICUs Across Ibero America